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高效薄层色谱法同时测定片剂剂型中缬沙坦和氢氯噻嗪的含量

HPTLC Method for the Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form.

作者信息

Shah N J, Suhagia B N, Shah R R, Patel N M

机构信息

Shri B. M. Shah College of Pharmaceutical Education & Research, Modasa-383 315, India.

出版信息

Indian J Pharm Sci. 2009 Jan;71(1):72-4. doi: 10.4103/0250-474X.51967.

Abstract

A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the simultaneous estimation of valsartan and hydrochlorothiazide in combined dosage forms. The stationary phase used was precoated silica gel 60F(254). The mobile phase used was a mixture of chloroform: methanol: toluene: glacial acetic acid (6:2:1:0.1 v/v/v/v). The detection of spots were carried out at 260 nm. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 300 to 800 ng/spot for valsartan and 100 to 600 ng/spot for hydrochlorothiazide. The limit of detection and the limit of quantification for the valsartan were found to be 100 and 300 ng/spot respectively and for hydrochlorothiazide 30 and 100 ng/spot respectively. The proposed method can be successfully used to determine the drug content of marketed formulation.

摘要

已开发并验证了一种简单、精确、准确且快速的高效薄层色谱法,用于同时测定复方制剂中缬沙坦和氢氯噻嗪的含量。所用固定相为预涂硅胶60F(254)。所用流动相为氯仿:甲醇:甲苯:冰醋酸(6:2:1:0.1 v/v/v/v)的混合物。斑点检测在260 nm波长下进行。该方法在线性、准确度、精密度和特异性方面进行了验证。缬沙坦的校准曲线在300至800 ng/斑点之间呈线性,氢氯噻嗪的校准曲线在100至600 ng/斑点之间呈线性。缬沙坦的检测限和定量限分别为100和300 ng/斑点,氢氯噻嗪的检测限和定量限分别为30和100 ng/斑点。所提出的方法可成功用于测定市售制剂的药物含量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2959/2810056/537e76299706/IJPhS-71-72-g001.jpg

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